Advancements are consistently sought in the medical field to improve the quality and care of patients. Many of these advances involve the use of electronic devices and equipment. Many of those devices and equipment are used in surgical or diagnostic settings. This is extremely problematic for patients, physicians, hospitals and others in the medical fields, as the electrical charges and emissions of energy from these devices may cause fires and localized explosions. In fact, the United States Food and Drug Administration (FDA) estimates that approximately 600 surgical fires occur in the United States each year. Many of these explosions traumatically affect patients and/or physicians, leading to disfigurement, scarring, and other injuries. They also expose medical facilities and physicians to civil liability.
In order for these fires or combustions to occur, three requirements must be satisfied (also known as the fire triangle). These requirements include ignition (energy or heat source), a fuel source, and an oxidizer. During medical procedures, electrical medical devices are often utilized. These medical devices, such as electrical surgical units (ESUs), e.g., cautery, diathermy, lasers, ultrasound, fiber-optic light sources and others emit energy at their point-of-use, thereby providing an “ignition” to a fire or combustion. Specifically, ESUs often generate sparks, or induce enough heat at their point-of-use, to cause combustion. “Fuel sources” encountered during surgical procedures include flammable gases and vapors from isopropyl alcohol and other alcohol-based surgical preparations used for sterilization of surgical sites prior to procedures. These substances may saturate and persist in surgical drapes, gowns, gauze and other items commonly found in an operating environment. Furthermore, many of the gases associated with anesthesia to limit or control a patient's pain, or to render a patient unconscious, are flammable. Invariably, these gases are administered to the facial region of a patient often exposing the head, face, throat, airway, and neck to severe damage should a fire or explosion occur. These gases may also disperse and linger under partial, or total body surgical drapes, exposing areas of the patient remote from the head to the risk of severe burns from fires or explosions. Once combustion of these gases or vapors occurs, especially in an oxygen rich surgical environment, there are an abundance of additional fuel sources such as surgical gauze, disposable drapes, gowns, the patient's own hair or skin, and other operating/procedure room materials which may combust or catch on fire.
“Oxidizers,” such as oxygen or nitrous oxide (which decomposes to nitrogen and oxygen), create the third element of the fire triangle and may act as accelerants. Oxidizers are routinely administered to patients during surgical procedures involving any type of sedation or anesthesia. While greater amounts of oxygen in environments increase the probability of fires or explosions, even normal oxygen levels found in typical atmospheric environments, e.g., air-conditioned/heated//climate controlled medical facilities, are sufficient to support fires or explosions. Some known devices and methods have attempted to contain oxygen in patients' airways to reduce the risk of combustion. Unfortunately, the oxygen commonly escapes and is found at, or near, sites where ESUs and other energy-emitting devices are used, and thus acts as an accelerant for fires and explosions when flammable gases or vapors are present. Moreover, these devices do not utilize response indicators from any other elements of the fire triangle, such as fuel sources, to prevent combustions. As such, these devices and methods would be ineffective against fires or explosions that may occur within normal oxygen levels found in surgical environments.
Moreover, most, if not all, known medical devices attempting to prevent combustions do not have the ability to adequately and efficiently detect gases. As mentioned, these gases may be administered to a patient, or may be found within the patient him or herself. For example, in the gastrointestinal (GI) tract, bacteria produce gases in the approximate ratios of 30% methane, 44% hydrogen, and 5% oxygen. Methane and hydrogen are flammable. Endoscopes, colonoscopies, and other GI procedural devices use ESUs, fiber-optic light sources, and other energy-emitting units during various procedures, which can ignite the methane and hydrogen. As the level of oxygen is too low to detect a response that signals an amount of oxygen which would facilitate an explosion, those known devices and methods which sense only oxygen, or sense the level of oxygen, would be futile against preventing explosions or fires.
Those known sensing medical devices, such as U.S. Pat. No. 7,291,145, also suffer from the above-described disadvantages. These devices are generally only limited to handheld cauterizers that detect the level of oxygen and shut down the energy source to the handheld cauterizer if a particular predetermined level of oxygen is detected during or immediately before the cauterizing process. These devices are only aimed at quantitatively measuring oxygen. These devices are only focused on determining the level of oxidizers in the surgical environment. As discussed, an explosion may occur within an environment having a normal concentration of oxygen. As such, these devices still would not prevent many surgical fires and combustions. Further, these devices only seek the level of oxygen; they do not identify any gases that may flammable, such as those found in universally used topical surgical site sterilization preparations and gases normally found within a patient's body.
Therefore, a need exists to overcome the problems with the prior art as discussed above.